European Commissions: Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Product https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-10/atmp_guidelines_en.pdf

European Medicines Agency: Guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products

https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-safety-efficacy-follow-risk-management-advanced-therapy-medicinal-products_en.pdf